Clinical Research Associate, Germany

Role Overview

• Performs site qualification, site initiation, interim monitoring, site management activities and close-out visits (performed on-site or remotely) ensuring regulatory, ICH-GCP and/or Good Pharmacoepidemiological Practices (GPP) and protocol compliance.
• Uses judgment and experience to evaluate overall performance of site and site staff and to provide recommendations regarding site-specific actions; immediately communicates/escalates serious issues to the project team and with guidance develops action plans.
• Maintains a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes.
• Verifies the process of obtaining informed consent has been adequately performed and documented for each subject/patient, as required/appropriate.
• Demonstrates diligence in protecting the confidentiality of each subject/patient.
• Assesses factors that might affect subject/patient’s safety and clinical data integrity at an investigator/physician site such as protocol deviation/violations and pharmacovigilance issues.
• Conducts Source Document Review of appropriate site source documents and medical records.
• Verifies required clinical data entered in the case report form (CRF) is accurate and complete.
• Applies query resolution techniques remotely and on site, and provides guidance to site staff as necessary, driving query resolution to closure within agreed timelines.
• Verifies site compliance with electronic data capture requirements.
• Ensures the investigator/physician site is aware of the requirement of archiving essential documents in accordance with local guidelines and regulations.
• Supports subject/patient recruitment, retention and awareness strategies.
• Must be able to quickly adapt, with the oversight of the Lead CRA, to changing priorities to achieve goals / targets.

Requirements

• Bachelor’s degree or RN in a related field or equivalent combination of education, training and experience
• Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements
• Experience in Real World Late Phase would be a plus
• Must demonstrate good computer skills and be able to embrace new technologies
• Excellent communication, presentation and interpersonal skills
• Fluency in German
• Preferable location is North/Mid/West Germany
• Ability to manage required travel of up to 75% on a regular basis.

Tech Stack

• Google Cloud Platform

Benefits

• We are passionate about developing our people, through career development and progression;
• supportive and engaged line management;
• technical and therapeutic area training;
• peer recognition and total rewards program.
• We are committed to building an inclusive culture – where you can authentically be yourself.